CA2415957A1 - Dry powder formulation comprising racecadotril - Google Patents
Dry powder formulation comprising racecadotril Download PDFInfo
- Publication number
- CA2415957A1 CA2415957A1 CA002415957A CA2415957A CA2415957A1 CA 2415957 A1 CA2415957 A1 CA 2415957A1 CA 002415957 A CA002415957 A CA 002415957A CA 2415957 A CA2415957 A CA 2415957A CA 2415957 A1 CA2415957 A1 CA 2415957A1
- Authority
- CA
- Canada
- Prior art keywords
- dry powder
- racecadotril
- pharmaceutical composition
- composition according
- powder pharmaceutical
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000000843 powder Substances 0.000 title claims abstract 10
- 239000000203 mixture Substances 0.000 title claims abstract 4
- ODUOJXZPIYUATO-UHFFFAOYSA-N 2-[[2-[(acetylthio)methyl]-1-oxo-3-phenylpropyl]amino]acetic acid (phenylmethyl) ester Chemical compound C=1C=CC=CC=1COC(=O)CNC(=O)C(CSC(=O)C)CC1=CC=CC=C1 ODUOJXZPIYUATO-UHFFFAOYSA-N 0.000 title claims 8
- 229960002281 racecadotril Drugs 0.000 title claims 8
- 108700040249 racecadotril Proteins 0.000 title claims 8
- 238000009472 formulation Methods 0.000 title abstract 2
- 206010012735 Diarrhoea Diseases 0.000 claims abstract 2
- 238000002560 therapeutic procedure Methods 0.000 claims abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 9
- 239000011248 coating agent Substances 0.000 claims 3
- 239000008187 granular material Substances 0.000 claims 3
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 claims 1
- 229920003134 Eudragit® polymer Polymers 0.000 claims 1
- 241000124008 Mammalia Species 0.000 claims 1
- CERQOIWHTDAKMF-UHFFFAOYSA-M Methacrylate Chemical compound CC(=C)C([O-])=O CERQOIWHTDAKMF-UHFFFAOYSA-M 0.000 claims 1
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical group COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
- A61K31/223—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of alpha-aminoacids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/12—Antidiarrhoeals
Landscapes
- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Emergency Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
A dry powder granulated formulation of the compound racedotril and its use in therapy in the treatment of diarrhoea.
Claims (11)
1. A dry powder pharmaceutical composition, suitable for oral use, comprising racecadotril in association with a pharmaceutically acceptable carrier.
2. A dry powder pharmaceutical composition according to claim 1 comprising racecadotril in granulated form.
3. A dry powder pharmaceutical composition according to claim 2, in which the granules of racecadotril are coated with a coating agent.
4. A dry powder composition according to claim 3 in which the granulate coating agent is a polymeric acrylate or methacrylate.
5. A dry powder pharmaceutical composition according to claim 4 in which the granulate coating agent is EUDRAGIT NE 3OD.
6. A dry powder pharmaceutical composition according to any one of claims 1 to 5 comprising a unit dose of from 1 to 50mg of racecadotril.
7. A pharmaceutical composition according to claim 6, comprising a unit dose of from 5 to 30mg of racecadotril.
8. A pharmaceutical composition according to claim 7 comprising, 6, 10, 18 or 30mg of racecadotril.
9. A dry powder pharmaceutical composition according to any one of claims 1 to 8, contained in a sachet form.
10. A dry powder pharmaceutical composition comprising racecadotril as claimed in any one of claims 1 to 9 for use as in therapy
11. A method of treatment of diarrhoea in mammals, including humans, which comprises administration of a composition as claimed in any one of claims 1 to 9.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP00401799.2 | 2000-06-23 | ||
| EP00401799 | 2000-06-23 | ||
| PCT/EP2001/007086 WO2001097801A2 (en) | 2000-06-23 | 2001-06-22 | Dry powder formulation comprising racecadotril |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2415957A1 true CA2415957A1 (en) | 2001-12-27 |
| CA2415957C CA2415957C (en) | 2010-08-10 |
Family
ID=8173739
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2415957A Expired - Lifetime CA2415957C (en) | 2000-06-23 | 2001-06-22 | Dry powder formulation comprising racecadotril |
Country Status (13)
| Country | Link |
|---|---|
| US (1) | US6919093B2 (en) |
| EP (1) | EP1294372B1 (en) |
| CN (2) | CN102151247A (en) |
| AT (1) | ATE301999T1 (en) |
| AU (1) | AU2001289606A1 (en) |
| BG (1) | BG66212B1 (en) |
| CA (1) | CA2415957C (en) |
| CZ (1) | CZ299591B6 (en) |
| DE (1) | DE60112756T2 (en) |
| DK (1) | DK1294372T3 (en) |
| ES (1) | ES2247163T3 (en) |
| SK (1) | SK287819B6 (en) |
| WO (1) | WO2001097801A2 (en) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2900823B1 (en) | 2006-05-15 | 2009-02-13 | Bioprojet Soc Civ Ile | NEW FORM OF ADMINISTRATION OF RACECADOTRIL. |
| CN101103960B (en) * | 2006-07-14 | 2010-12-08 | 海南盛科生命科学研究院 | Dry mixed suspension containing racecadotril and preparation method thereof |
| EP2462922A1 (en) | 2010-12-10 | 2012-06-13 | Bioprojet | New form of administration of enkephalinase inhibitor |
| CN102166197B (en) * | 2011-04-25 | 2012-09-05 | 四川百利药业有限责任公司 | Racecadotril granules and production process thereof |
| EP2768537B1 (en) * | 2011-10-18 | 2019-02-20 | Purdue Pharma LP | Acrylic polymer formulations |
| RU2632441C2 (en) | 2012-06-28 | 2017-10-04 | МакНЕЙЛ-ППС, ИНК. | Lipid compositions of racecadotril |
| US9114171B2 (en) | 2012-06-28 | 2015-08-25 | Mcneil-Ppc, Inc. | Racecadotril liquid compositions |
| PT2866802T (en) | 2012-06-28 | 2016-09-05 | Johnson & Johnson Consumer Inc | Racecadotril liquid compositions |
| US9801819B2 (en) | 2012-06-28 | 2017-10-31 | Johnson & Johnson Consumer Inc. | Racecadotril compositions |
| TR201801726T4 (en) * | 2012-12-26 | 2018-03-21 | Ilko Ilac Sanayi Veticaret A S | RASECADOTRIL AND PHARMACEUTICAL COMPOSITIONS. |
| EP2918268A1 (en) | 2014-03-10 | 2015-09-16 | Galenicum Health S.L. | Pharmaceutical compositions comprising an active agent |
| ES2555484T1 (en) | 2014-05-26 | 2016-01-04 | Galenicum Health S.L. | Pharmaceutical compositions containing an active agent |
| MA40859A (en) | 2014-10-29 | 2017-09-05 | Johnson & Johnson Consumer Inc | CADOTRIL PARTICLES |
| EP3558272A1 (en) | 2016-12-23 | 2019-10-30 | Hermes Arzneimittel GmbH | Oral pharmaceutical composition with improved taste-masking properties |
| WO2018163195A1 (en) | 2017-03-06 | 2018-09-13 | Athena Drug Delivery Solutions Pvt Ltd. | A pharmaceutical composition comprising racecadotril and process for preparing the same |
| CN109589310A (en) * | 2017-10-01 | 2019-04-09 | 北京万全德众医药生物技术有限公司 | Racecadotril Dried Suspension and preparation method thereof |
| GB2586201B (en) * | 2019-05-14 | 2023-05-24 | Orbit Pharmaceuticals | A stable powder formulation of racecadotril |
| EP4056171A1 (en) | 2021-03-12 | 2022-09-14 | Athena Pharmaceutiques SAS | Taste masked racecadotril tablet composition and process for preparation thereof |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2480747A1 (en) * | 1980-04-17 | 1981-10-23 | Roques Bernard | AMINO ACID DERIVATIVES AND THEIR THERAPEUTIC APPLICATION |
| ZA919510B (en) * | 1990-12-05 | 1992-10-28 | Smithkline Beecham Corp | Pharmaceutical compositions |
| GR1002332B (en) * | 1992-05-21 | 1996-05-16 | Mcneil-Ppc Inc. | Novel simethicone containing pharmaceutical compositions. |
| US5914132A (en) * | 1993-02-26 | 1999-06-22 | The Procter & Gamble Company | Pharmaceutical dosage form with multiple enteric polymer coatings for colonic delivery |
| EP0914822A4 (en) * | 1996-03-14 | 2002-08-07 | Bayer Ag | Rapid-release microdispersible ecadotril preparation |
| US6649186B1 (en) * | 1996-09-20 | 2003-11-18 | Ethypharm | Effervescent granules and methods for their preparation |
| US6270804B1 (en) * | 1998-04-03 | 2001-08-07 | Biovail Technologies Ltd. | Sachet formulations |
| GB0015490D0 (en) * | 2000-06-23 | 2000-08-16 | Smithkline Beecham Lab | Novel formulations |
-
2001
- 2001-06-22 CN CN2011100456773A patent/CN102151247A/en active Pending
- 2001-06-22 ES ES01969310T patent/ES2247163T3/en not_active Expired - Lifetime
- 2001-06-22 CA CA2415957A patent/CA2415957C/en not_active Expired - Lifetime
- 2001-06-22 SK SK76-2003A patent/SK287819B6/en not_active IP Right Cessation
- 2001-06-22 DK DK01969310T patent/DK1294372T3/en active
- 2001-06-22 CN CNA018131867A patent/CN1635884A/en active Pending
- 2001-06-22 AU AU2001289606A patent/AU2001289606A1/en not_active Abandoned
- 2001-06-22 EP EP01969310A patent/EP1294372B1/en not_active Expired - Lifetime
- 2001-06-22 AT AT01969310T patent/ATE301999T1/en active
- 2001-06-22 DE DE60112756T patent/DE60112756T2/en not_active Expired - Lifetime
- 2001-06-22 WO PCT/EP2001/007086 patent/WO2001097801A2/en active IP Right Grant
- 2001-06-22 CZ CZ20030185A patent/CZ299591B6/en not_active IP Right Cessation
-
2003
- 2003-01-13 US US10/347,332 patent/US6919093B2/en not_active Expired - Lifetime
- 2003-01-20 BG BG107481A patent/BG66212B1/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CN1635884A (en) | 2005-07-06 |
| DE60112756T2 (en) | 2006-06-08 |
| CZ299591B6 (en) | 2008-09-10 |
| DE60112756D1 (en) | 2005-09-22 |
| BG66212B1 (en) | 2012-05-31 |
| WO2001097801A3 (en) | 2002-09-12 |
| BG107481A (en) | 2003-09-30 |
| CZ2003185A3 (en) | 2003-05-14 |
| CA2415957C (en) | 2010-08-10 |
| ES2247163T3 (en) | 2006-03-01 |
| WO2001097801A2 (en) | 2001-12-27 |
| ATE301999T1 (en) | 2005-09-15 |
| EP1294372A2 (en) | 2003-03-26 |
| SK287819B6 (en) | 2011-11-04 |
| DK1294372T3 (en) | 2005-09-19 |
| AU2001289606A1 (en) | 2002-01-02 |
| US20030166718A1 (en) | 2003-09-04 |
| EP1294372B1 (en) | 2005-08-17 |
| US6919093B2 (en) | 2005-07-19 |
| CN102151247A (en) | 2011-08-17 |
| SK762003A3 (en) | 2003-07-01 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKEX | Expiry |
Effective date: 20210622 |